Abdominal instrument and method

ABSTRACT

A surgical instrument ( 100 ) for placement of a movement restriction device ( 10 ) for use in a surgical procedure for treating reflux disease in a patient. The instrument comprises a sleeve ( 113 ) and a holding device ( 111 ) configured to engage the movement restriction device, wherein the holding device is configured to be placed within the sleeve and be displaceable in relation to the sleeve. The instrument further comprises a first handling portion ( 101 ) connected to the sleeve, and a second handling portion ( 102 ) connected to the holding device. The handling of at least one of the first and second handling portion creates relative displacement of the holding device in relation to the sleeve, which disengages the holding device from the movement restriction device for performing the placement of the movement restriction device.

This application is a National Stage Entry of PCT/EP2018/072042, whichdesignates the U.S. and is tiled Aug. 14, 2018, and claims priority fromSwedish Patent Application 1750996-9, tiled Aug. 16, 2017, the entirecontents of each of which are hereby incorporated by reference in thisapplication.

TECHNICAL FIELD

The present invention relates generally to an instrument for treatingGastro Esophageal Reflux Disease (GERD) and/or Obesity in a humanpatient.

BACKGROUND

Gastro Esophageal Reflux Disease (GERD), or acid reflux disease, is achronic condition resulting in mucosal damage in the esophagus producedby the recurring occurrence of acid reflux in the esophagus. This iscommonly due to transient or permanent changes in the barrier betweenthe esophagus and the stomach. This can be due to incompetence of thelower esophageal sphincter (LES), transient LED relaxation, impairedexpulsion of gastric reflux from the esophagus, or a hiatal hernia.

Gastro Esophageal Reflux Disease can be treated in a number of ways,where surgical treatments are sometimes preferred over longtimemedication. A standard surgical treatment is Nissen funduplication wherethe upper portion of the stomach is wrapped around LES to strengthen thesphincter and prevent acid reflux and to repair hiatal hernia. Thisprocedure often done laparoscopically and is hard to performtransorally.

Another surgical treatment is to create an anti-reflux valve of fundustissue. This treatment can be performed transorally, by using anendoscope to visualize the Z-line and attract tissue creating a suitablevalve which is then fastened. Such treatment is hard and requires askilled endoscopist. It includes numerous steps in each procedure,typically manipulating tissue more than two times and applying aplurality of individual fasteners to create an anti-reflux valve. Somepatients also suffer from hiatal hernia which is an additional step totreat. This both increases time consumption of the endoscopist and eachadded step increase the risk of mistakes which can potentially be hardto undo.

From experience with implantation of medical devices, it is known thatsutures between an implanted device and human tissue will not hold inthe long term. For long term implantation of a device, there are twopossibilities to keep the device in place. A first solution has been tosuture human tissue to human tissue, to thereby keep the device inplace. A second approach has been to provide sutures holding a device inplace in the short term and to allow in-growth of human tissue into thedevice for holding the device in place over the long term.

A problem with providing an implantable device associated with theesophagus is that the outer surface of the esophagus is only comprisedof esophagus muscle tissue, which is very easy to damage or migratethrough. This is probably one reason why the Anglechik prosthesisdescribed above has resulted in many complications, such as migration.

The stomach, on the other hand, has a serosa on its outside, therebyproviding a much stronger membrane for suturing. Thus, suturing a devicedirectly to the stomach wall provides a better result than suturing animplanted device to the esophagus.

Today, there exists a need for a long term treatment of GERD that ismore effective than prior treatments and which does not result in anysevere complications.

Surgical treatments in the upper gastrointestinal tract are todaygenerally complicated to do in a minimal or non-invasive manner. Thetreatment's level of invasiveness depends on the arrangement of surgicalinstruments and the handling thereof. Thus, there exists a need for aninstrument for performing surgical operations in a more effective waythan prior instruments for surgical treatments in the stomach cavity.

SUMMARY OF THE INVENTION

It is an object of the present invention to overcome, or at leastreduce, some of the problems associated with existing surgicaltreatments of Gastro Esophageal Reflux Disease (GERD). It is anotherobject of the present invention to provide an instrument and method fortreating Gastro Esophageal Reflux Disease. These objects and others areobtained by appended claims.

A surgical instrument for placement of a movement restriction device foruse in a surgical procedure for treating reflux disease in a patient isprovided. The surgical instrument comprises a sleeve and a holdingdevice configured to engage the movement restriction device, wherein theholding device is configured to be placed within the sleeve and bedisplaceable in relation to the sleeve. The instrument further comprisesa first handling portion connected to the sleeve, and a second handlingportion connected to the holding device. The handling of at least one ofthe first and second handling portion creates relative displacement ofthe holding device in relation to the sleeve, which disengages theholding device from the movement restriction device for performing theplacement of the movement restriction device. The instrument providessecure holding of the movement restriction device during the surgicalprocedure as well as easy disengagement upon completion of the surgicalprocedure. The instrument also reduces the risk that the movementrestriction device is removed or displaced from its fixated positionwhen the instrument is retracted.

According to one embodiment, the surgical instrument comprises a distalportion, configured to enter the body of the patient in use, and aproximal portion, configured to remain outside of the body of thepatient in use. The holding device is positioned in the distal portionand the first and second handling portions are positioned in theproximal portion.

According to one embodiment, the holding device is positioned on anelongated member connected to the second handling portion.

According to one embodiment, the holding device comprises a protrudingmember configured to engage a recess of the movement restriction device.

According to one embodiment, the first handling portion is linearlydisplaceable in relation to the second handling portion along a primarylength axis of the instrument, and in an alternative embodiment, thefirst handling portion is rotationally displaceable in relation to thesecond handling portion around a primary length axis of the instrument.

The first handling portion may comprise a threaded portion and at leastone of the second handling portion and the sleeve comprises acorresponding threaded portion, such that rotational displacement of thefirst handling portion in relation to the second handling portioncreates linear displacement of the first handling portion in relation tothe second handling portion, along the primary length axis of theinstrument.

According to one embodiment, the distal portion is bent in relation tothe primary length axis of the instrument. The distal portion may bebent more than 20° in relation to the primary length axis of theinstrument, or more than 30° in relation to the primary length axis ofthe instrument, or more than 45° in relation to the primary length axisof the instrument, or more than 60° in relation to the primary lengthaxis of the instrument, or more than 75° in relation to the primarylength axis of the instrument, or more than 90° in relation to theprimary length axis of the instrument. The bend enables the instrumentto be placed in the required positioned by rotation of the instrument.

The distal portion of the sleeve may be rigid and a distal portion ofthe elongated member is flexible, alternatively the distal portion ofthe sleeve is flexible and a distal portion of the elongated member isrigid.

According to one embodiment, the distal portion is flexible such thatthe distal portion can be bent in relation to the primary length axis ofthe instrument. The distal portion may be operably flexible such thatthe surgeon can bend the distal portion during the surgical procedure,which may mean that the elongated member is operably flexible such thatthe surgeon can bend the distal portion during the surgical procedure.In one embodiment the operably flexible distal portion is configured tobe bent in excess of 30°. In one embodiment the operably flexible distalportion is configured to be bent in excess of 45°. In one embodiment theoperably flexible distal portion is configured to be bent in excess of60°. In one embodiment the operably flexible distal portion isconfigured to be bent in excess of 75°. In one embodiment the operablyflexible distal portion is configured to be bent in excess of 90°.

According to one embodiment, the proximal portion further comprises athird handling portion for operating the operably flexible distalportion during the surgical procedure. The third handling portion may belinearly displaceable in relation to the second handling portion along aprimary length axis of the instrument, for operating the operablyflexible distal portion during the surgical procedure. In an alternativeembodiment, the third handling portion is rotationally displaceable inrelation to the second handling portion around a primary length axis ofthe instrument, for operating the operably flexible distal portionduring the surgical procedure.

According to one embodiment, the third handling portion comprises athreaded portion and the second handling portion comprises acorresponding threaded portion, such that rotational displacement of thethird handling portion in relation to the second handling portioncreates linear displacement of the third handling portion in relation tothe second handling portion along the primary length axis of theinstrument, for operating the operably flexible distal portion duringthe surgical procedure.

According to one embodiment, the sleeve comprises a rigid portion and aflexible portion configured to bend, and wherein the sleeve isdisplaceable relative to the holding device, such that the point on thesurgical instrument in which the bending may start can be moved.

The surgical instrument according to any one of the embodiments hereinmay be configured to be inserted into the abdomen of a patient through atrocar.

According to one embodiment, the first handling portion comprises atleast one groove or recess adapted to house at least part of the secondhandling portion. Preferably, the first handling portion comprises atleast two grooves or recesses running along the length axis of theinstrument. The grooves or recesses supports the second handling portionduring displacement. Preferably, the grooves or recesses prevent orhinders movement in the width axis of the instrument.

According to one embodiment, the at least one groove or recess isadapted to allow relative displacement of the second handling portionand the first handling portion. Preferably, at least part of the secondhandling portion is positioned in the at least one groove or recessduring relative displacement of the first handling portion in relationto the second handling portion.

According to some embodiments, the holding device is integrated with theelongated member connected to the second handling portion. The holdingdevice may be integrally formed in one piece with the elongated member.This can be achieved by providing the elongated member in the form of awire.

According to some embodiments, the second handling portion is integratedwith the elongated member. The second handling portion may be integrallyformed in one piece with the elongated member. This can be achieved byproviding the elongated member in the form of a wire.

According to some embodiments, the second handling portion is formed ofan end of the elongated member distal to the movement restrictiondevice. The second handling portion can be provided by looping theelongated member at an end thereof. In examples where the elongatedmember is a wire, the wire can be looped to form the second handlingportion. Parts of the loop can then be positioned in the at least onegroove or recess on the first handling portion. The loop allows a userof the instrument to easily grasp the second handling portion.

According to some embodiments, the holding device is formed of an end ofthe elongated member proximal to the movement restriction device. Inexamples where the elongated member is a wire, an end of the wire may bethe holding device. A recess in the movement restriction device may bedimensioned such that the end of the wire can engage the recess.

In some embodiments at least part of the second handling portion has acurved shape.

The disclosed elements of a surgical instrument for placement of amovement restriction device for use in a surgical procedure for treatingreflux disease in a patient, may be used for other applications whereimplants or surgical tools needs to be held and released inside of thebody of the patient. A general instrument may comprise a sleeve, aholding device configured to engage a medical implant or surgical tool,wherein the holding device is configured to be placed within the sleeveand be displaceable in relation to the sleeve, a first handling portionconnected to the sleeve, and a second handling portion connected to theholding device. The handling of at least one of the first and secondhandling portion creates relative displacement of the holding device inrelation to the sleeve, which disengages the holding device from themedical implant or surgical tool for performing the placement of themedical implant or surgical tool.

A surgical method for treating reflux disease in a patient by implantinga movement restriction device with use of a surgical instrument isfurther provided. The surgical method comprises making at least oneincision in an abdomen of the patient, dissecting in an area comprisinga fundus of a stomach, at least partially inserting the surgicalinstrument holding the movement restriction device in the abdomen of thepatient, placing the movement restriction device contacting the fundusof the stomach, on the outside thereof, fixating the movementrestriction device to the fundus wall, and disengaging the movementrestriction device by displacing the sleeve in relation to the holdingdevice.

According to one embodiment, the step of fixating the movementrestriction device comprises invaginating the movement restrictiondevice in the stomach fundus wall using stomach to stomach sutures orstaplers.

According to one embodiment, the surgical method further comprises thestep of fixating the stomach to the esophagus using suture of staplers.

In embodiments where the distal portion of the surgical instrument isbent, the surgical procedure may comprise the step of rotating theinstrument with the bend for positioning the movement restrictiondevice.

In embodiments where the distal portion of the surgical instrument isoperably flexible, the surgical procedure may comprise the step ofoperating the operably flexible distal portion for positioning themovement restriction device.

According to one embodiment, the holding device comprises a protrudingmember and the movement restriction device comprises a recess configuredto engage the protruding member, and the step of disengaging themovement restriction device by displacing the sleeve in relation to theholding device comprises disengaging the protruding member from therecess.

The surgical method may be a laparoscopic surgical method, in which casethe method may further comprise at least one of the steps of:

introducing a tube through the abdominal wall,

filling a fluid or gas into the abdominal cavity,

introducing two or more trocars into the abdominal cavity,

introducing a camera into the abdominal cavity through one of thetrocars,

dissecting in the abdomen using a laparoscopic dissection instrument,

introducing the surgical instrument into the abdominal cavity through atrocar,

suturing or stapling using a laparoscopic suturing or staplinginstrument, and

removing the surgical instrument into the abdominal cavity through atrocar.

Please note that any embodiment or part of embodiment as well as anymethod or part of method or any apparatus or part of apparatus or anyfeature or part of feature or any system or part of system or any figureor part of figure could be combined in any applicable way. All examplesherein should be seen as part of the general description and thereforepossible to combine in any way in general terms.

BRIEF DESCRIPTION OF DRAWINGS

The invention is now described, by way of example, with reference to theaccompanying drawings, in which:

FIG. 1 shows a patient when a movement restriction device has beenimplanted,

FIG. 2 shows an anatomic view of the stomach, lower portion of theesophagus and the diaphragm.

FIG. 3 shows the surgical instrument, according to a first embodiment,

FIG. 4 shows the surgical instrument, according to a first embodiment,in its straight state, in section.

FIG. 5 shows the surgical instrument, according to a first embodiment,in its bent state, in section.

FIG. 6A shows the surgical instrument, according to a first embodiment,when disengaging the movement restriction device, in section.

FIG. 6B shows the surgical instrument, according to an alternative firstembodiment, when disengaging the movement restriction device, insection.

FIG. 7A shows the surgical instrument, according to a second embodiment,when disengaging the movement restriction device, in section.

FIG. 7B shows the surgical instrument, according to a second embodiment,when disengaging the movement restriction device, in section.

FIGS. 8A-8D shows steps of a surgical procedure for treating refluxdisease, using the surgical instrument.

FIG. 9 shows the esophagus and upper part of the stomach when themovement restriction device has been positioned, in section.

FIG. 10 shows the medical instrument according to a third embodiment.

FIG. 11A shows the surgical instrument, according to a third embodiment,when engaging the movement restriction device.

FIG. 11B shows the surgical instrument, according to a third embodiment,when disengaging the movement restriction device.

FIG. 12A shows the surgical instrument, according to a third embodimentwhen positioned inside a trocar, engaging the movement restrictiondevice.

FIG. 12B shows the surgical instrument, according to a third embodimentwhen positioned inside a trocar, engaging the movement restrictiondevice.

DETAILED DESCRIPTION

In the following a detailed description of embodiments of the inventionwill be given with reference to the accompanying drawings. It will beappreciated that the drawings are for illustration only and are not inany way restricting the scope of the invention. Thus, any references todirections, such as “up” or “down”, are only referring to the directionsshown in the figures. It should be noted that the features having thesame reference numerals have the same function, it should further benoted that features in the different embodiments having different firstdigit but the same last two digits are similar i.e. 110, 210 and 310. Afeature in one embodiment could thus be exchanged for a feature fromanother embodiment having the same last two digits unless clearlycontradictory. The descriptions of the similar features having the samelast two digits should thus be seen as complementing each other indescribing the fundamental idea of the feature and thereby showing thefeatures versatility.

The terms cardia sphincter, cardia muscle and lower esophageal sphincteris to be understood as the sphincter in the esophagus hindering stomachcontent and stomach acid from reaching the esophagus.

Surgical procedure is to be understood as any type of surgicalprocedure, open surgical procedure or laparoscopic surgical procedure.In all of the embodiments herein the surgical instrument may beconfigured to be inserted into the abdomen of a patient through alaparoscopic trocar. The surgical instrument may in such cases beconfigured for insertion into a laparoscopic trocar having a diameter of80 mm, 100 mm, 120 mm or 150 mm.

FIG. 1 shows a human patent 1 when a surgical procedure for thetreatment of reflux disease has been performed. A movement restrictiondevice 10 has been placed in the fundus portion of the stomach 12. Thefunction and the operation of the movement restriction device 10 will bedescribed and explained in detail in the following description.

FIG. 2 shows the stomach region of a patient comprising the esophagus 5which passes through the thoracic diaphragm 18 which further supportsthe cardia sphincter 14, which in turn prevents the stomach content andstomach acid from reaching the area of the esophagus 5. The esophagus 5is a substantially tube shaped tissue leading to the stomach 12comprising stomach tissue. The esophagus has an esophagus center axis 4,being substantially aligned with a cranial-caudal axis of the patient inand having a substantially circular circumference substantially alignedwith a horizontal plane of the erect patient. The esophagus 5 furtherhas an inner 2 and outer 3 substantially cylindrical surface extendingradially in relation to the esophagus 5 center axis 4.

In a patient with reflux disease, the cardia sphincter 14 has slid upthrough the foramen 18′ in the thoracic diaphragm 18 and thus is nolonger supported by the thoracic diaphragm 18. Reflux disease makes thestomach content and stomach acid enter the esophagus 5 and creates aburning sensation in the esophagus tissue, which in long term exposurecould affect the cell structure of the inner layer of esophagus tissuetransforming the structure from a squamous epithelium to a glandepithelium, a transformation which increases the risk of adenocarcinoma.The esophagus 5 connects to the stomach at the gastroesophageal junction8 which normally is placed below the thoracic diaphragm 18. In the eventthat the cardia sphincter slides up through the foramen 18′ in thediaphragm 18, the gastroesophageal junction 8 may be positioned in theforamen 18′ or in thorax.

FIG. 3 shows a first embodiment of a surgical instrument 100 forplacement of a movement restriction device 110 for use in the surgicalprocedure for treating reflux disease in a patient. The instrument 100is made up of a distal portion DP, configured to be inserted into theabdomen of the patient during the surgical procedure, and a proximalportion PP configured to remain outside the body of the patient, and behandled by the surgeon during the surgical procedure. The instrument 100comprises a sleeve 113, the major part of which being placed at thedistal portion DP. The sleeve 113 is connected to or, integrated with, afirst handling portion 101, which is displaceable in relation to thesecond handling portion 102. In the embodiment shown in FIG. 3 , aportion of the distal portion is flexible, such that the distal portioncan flex and thus bend in relation to a primary length axis LA of theinstrument 100. In the embodiment shown in FIG. 3 , the flexible portionof the distal portion DP is operably flexible such that the surgeon canbend the distal portion during the surgical procedure. In alternativeembodiments, the flexible portion can only be bent manually, outside ofthe patient and ahead of the surgical procedure, such that a suitableangle of the flexible distal portion can be set for the current patient.

Returning to the embodiment shown in FIG. 3 , the distal portion of thesleeve 113 comprises a flexible sleeve portion 112. The flexible sleeveportion 112 could for example comprise a helically wound metal sleeve, aflexible sleeve made from a polymer material, a woven flexible metalsleeve, or a combination of the above.

The distal portion DP of the instrument 100 further comprises a holdingdevice 111 configured to engage and thus hold the movement restrictiondevice 110 during the surgical procedure. The holding device 111 isconfigured to be placed within the sleeve 113 and be displaceable inrelation to the sleeve 113. In the embodiment shown in FIG. 3 , theholding device 111 comprises a protruding member configured to engage arecess of the movement restriction device 110, and thereby hold themovement restriction device 110. The movement restriction device isconnected to, or integrated with, a third handling portion 103 connectedto the holding device 111, which is displaceable in relation to thesecond handling portion 102 (which will be further elaborated on withreference to FIGS. 4-6 ).

FIGS. 4 and 5 shows the surgical instrument 100 according to the firstembodiment, in section. To start with the most distal part, the movementrestriction device 110 is held by the holding device 111 having aprotruding member which engages a recess of the movement restrictiondevice 110. The protruding member is fixated to or integrated with theuppermost portion 114′ of an elongated member 114. The elongated member114 is operably flexible such that the surgeon can bend the distalportion DP during the surgical procedure.

The operation device creating the bending motion comprises a pluralityof bending elements 116 having a triangular cross-section, such that thebending elements 116 contacts each other on the left side of theelongated member 114 and are separated by a void on the right side ofthe elongated member 114. A pull wire 115 is fixated to the right sideof the uppermost bending element 116 and configured to exert a pullingforce on the uppermost bending element, whereby the geometry of thebending elements 116 forces the elongated member 114 to bend and thevoids between the bending elements 116 to become smaller. The flexiblesleeve portion 112 bends along with the elongated member 114 placedtherein. As the sleeve 113 comprises a rigid portion and a flexiblesleeve portion 112 configured to bend, and as the sleeve 113 isdisplaceable relative to the elongated member 114 and the holdingdevice, the point on the surgical instrument in which the bending maystart can be moved by displacing the sleeve 113 which creates a furthermeans for adjusting the instrument.

The proximal portion of the elongated member 114 is connected to, orintegrated in, the second handling portion 102, and thus is theuppermost portion 114′ of an elongated member 114 and the holding device111 connected to the second handling portion 102. The pull wire 115 isconnected to a third handling portion 103 being the most distal portionof the instrument 100. The third handling portion 103 is rotationallydisplaceable in relation to the second handling portion 102 around aprimary length axis LA of the instrument, for operating the pull wire115 and thus the operably flexible distal portion during the surgicalprocedure. The third handling portion 103 comprises a threaded portion103T and the second handling portion 102 comprises a correspondingthreaded portion 102T, such that rotational displacement of the thirdhandling portion 103 in relation to the second handling portion 102creates linear displacement of the third handling portion 103 inrelation to the second handling portion 102, along the primary lengthaxis LA of the instrument 100. The linear displacement pulls the pullwire 115 in the proximal direction causing the operably flexible distalportion to bend.

FIG. 5 shows the first embodiment of the surgical instrument 100 whenthe third handling portion 103 has been operated by rotation such thatthe pull wire 115 has been pulled a distance sufficient for the bendingelements 116 to bend the operably flexible distal portion to an angle αbetween the main length axis LA of the instrument and a bend axis BA,being a length axis of the uppermost portion 114′ of an elongated memberand of the holding device 111. In one embodiment, the operably flexibledistal portion is configured to bend to an angle α exceeding 20°. In oneembodiment the operably flexible distal portion is configured to bend toan angle α exceeding 30°. In one embodiment the operably flexible distalportion is configured to bend to an angle α exceeding 45°. In oneembodiment the operably flexible distal portion is configured to bend toan angle α exceeding 60°. In one embodiment the operably flexible distalportion is configured to bend to an angle α exceeding 75°. In oneembodiment the operably flexible distal portion is configured to bend toan angle α exceeding 90°.

In an alternative embodiment, the third handling portion is a linearlydisplaceable handling portion directly causing a linear pull on the pullwire 115. I.e. the third handling portion is in such an embodimentslideably connected to the second handling portion and can in such anembodiment be pulled in a proximal direction, along a primary lengthaxis LA of the instrument, for creating the bending of the operablyflexible distal portion.

Turning now to the operation of the holding device 111. FIG. 6A showsthe surgical instrument 100 in accordance with the first embodiment inits straight configuration, in section. The first handling portion 101is linearly displaceable in relation to the second handling portion 102along the primary length axis LA of the instrument. As the firsthandling portion 101 is integrated with the sleeve 113, lineardisplacement of the first handling portion 101 in the distal directioncauses the distalmost portion of the sleeve 113 to also move in thedistal direction and thus be advanced over and passed the uppermostportion 114′ of an elongated member 114 and passed the holding device111. This relative displacement of the sleeve 113 and the holding device111 disengages the holding device 111 from the movement restrictiondevice 110, by the protruding member of the holding device beingdisengaged from the recess in the movement restriction device 110. Thesurgical instrument 100 thus places the movement restriction deviceinside of the body of the patient and can then be removed from theabdomen.

FIG. 6B shows an alternative embodiment of the surgical instrument 100in which the first handling portion 101 is rotationally displaceable inrelation to the second handling 102 portion around a primary length axisLA of the instrument. The first handling portion 101 comprises athreaded portion 101T and the second handling portion 102 and/or thesleeve 113 comprises a corresponding threaded portion 113T, such thatrotational displacement of the first handling portion 101 in relation tothe second handling portion 102 creates linear displacement of the firsthandling portion 101 in relation to the second handling portion 101,along the primary length axis LA of the instrument.

FIGS. 7A and 7B shows a second embodiment of the surgical instrument200. In the second embodiment, the distal portion DP is bent in relationto the primary length axis LA of the instrument 200 by means of a fixedbend. In the embodiment shown in FIG. 7A the primary length axis LA isbent in relation to a bent axis BA of the holding device 211 andmovement restriction device 210 with an angle β. In one embodiment, theangle β of the bend is exceeding 20°. In one embodiment, the angle β ofthe bend is exceeding 30°. In one embodiment the angle β of the bend isexceeding 45°. In one embodiment the angle β of the bend is exceeding60°. In one embodiment the angle β of the bend is exceeding 75°. In oneembodiment the angle β of the bend is exceeding 90°.

In the embodiment shown in FIG. 7A, the sleeve 213 is rigid andcomprises a rigid bend 213B while a distal portion of the elongatedmember 214 is flexible and creates a flexible bend 214B within thesleeve 213, such that the elongated member 214 can be displaced inrelation to the sleeve 213 even though the bend is fixed.

In an alternative embodiment, a distal portion of the elongated member214 is rigid and comprises a rigid bend, while a distal portion of thesleeve 213 is flexible and forms a flexible bend, such that theelongated member 214 can be displaced in relation to the sleeve 213 eventhough the bend is fixed.

FIG. 7B shows the second embodiment of the surgical instrument 200 inthe state when the elongated member 214 and thus the holding device 211has been displaced in relation to the sleeve 213, such that the movementrestriction device 210 has been disengaged from the instrument.

The instrument according to the second embodiment is shown with thesleeve 213 being directly linearly displaceable in relation to theelongated member 214, however, it is equally conceivable that theinstrument according to the second embodiment is equipped with therotating first handling portion such as shown in FIG. 6B.

FIGS. 8A-8D shows a surgical method for treating reflux disease in apatient by implanting a movement restriction device 310 with use of thesurgical instrument 300 according to one of the embodiments herein.

In FIG. 8A, the instrument 300 holding the movement restriction device310 has been inserted into the abdomen of the patient though an incisionmade in the abdomen of the patient. The procedural step shown in FIG. 8Ahas been preceded by the step of dissecting in an area comprising afundus of a stomach, such that the movement restriction device 310 canbe placed engaging the fundus of the patient. A grasper is used forholding the stomach wall of the fundus while the surgical instrumentoperates to place the movement restriction device contacting the fundusof the stomach, on the outside thereof. In the embodiment when thesurgical instrument is bent, the instrument may be positioned by thestep of rotating the instrument with the bend for positioning themovement restriction device. In the embodiments where the distal portionof the surgical instrument is operably flexible, the instrument may bepositioned by the step of operating the operably flexible distal portionfor positioning the movement restriction device.

The disclosed elements of a surgical instrument for placement of amovement restriction device for use in a surgical procedure for treatingreflux disease in a patient, may be used for other applications whereimplants or surgical tools needs to be held and released inside of thebody of the patient. A general instrument may comprise a sleeve, aholding device configured to engage a medical implant or surgical tool,wherein the holding device is configured to be placed within the sleeveand be displaceable in relation to the sleeve, a first handling portionconnected to the sleeve, and a second handling portion connected to theholding device. The handling of at least one of the first and secondhandling portion creates relative displacement of the holding device inrelation to the sleeve, which disengages the holding device from themedical implant or surgical tool for performing the placement of themedical implant or surgical tool.

In the surgical procedure shown in FIGS. 8A-8D, the movement restrictiondevice is invaginated in the stomach fundus wall by means of stomach tostomach sutures 301 by means of a surgical suturing needle. It ishowever equally conceivable that a stapling device is used in the stepof invaginating the movement restriction device in the stomach wall.

FIGS. 8B and 8C shows the further suturing for invaginating the movementrestriction device 310, such that the movement restriction device 310 isplaced fixedly in the created pouch on the outside of the stomach wall,on the outside thereof.

FIG. 8D shows the step of the instrument disengaging the movementrestriction device by displacing the sleeve 313 in relation to theholding device 311. In the embodiment shown in FIGS. 8A-8D, the holdingdevice 311 comprises a protruding member and the movement restrictiondevice 310 comprises a recess configured to engage the protrudingmember, such that the step of disengaging the movement restrictiondevice 310 by displacing the sleeve 313 in relation to the holdingdevice 311 comprises disengaging the protruding member from the recess.Subsequently the instrument 310 is removed from the abdomen of thepatient.

The procedural steps shown on FIGS. 8A-8D may be steps of a laparoscopicsurgical method, in which case the surgical method further comprises thesteps of introducing a tube through the abdominal wall for filling afluid or gas into the abdominal cavity, to thereby expand the abdominalcavity creating visual space. The method further comprises introducingtwo or more trocars into the abdominal cavity and introducing a camerainto the abdominal cavity through one of the trocars. Next, the methodcomprises dissecting in the abdomen using a laparoscopic dissectioninstrument, before the introduction of the surgical instrument into theabdominal cavity through a trocar. The fixation by means of sutures orstaplers is performed using a laparoscopic suturing or staplinginstrument, and the method is concluded by the removal of the surgicalinstrument into the abdominal cavity through a trocar.

FIG. 9 shows the esophagus and the upper portion of the stomach when themovement restriction device has been implanted in the fundus wall. Themovement restriction device is fixated by invagination in the stomach 12wall by means of a plurality of sutures 305. In the embodiment shown inFIG. 9 , the fixation of the movement restriction device has beenpreceded by the fixation of the stomach fundus wall to the esophagus bymeans of sutures 305′ for the fixed placement of the movementrestriction device 310. The movement restriction device 310 ispreferably made from an elastic, bio-compatible silicone material whichmay be provided with at least one layer. For example, a metal layer, aParylene layer, a polytetrafluoroethylene layer or a polyurethane layer.

The movement restriction device may have a maximum diameter of less than40 mm, or a maximum diameter of less than 30 mm, or a maximum diameterof less than 20 mm.

FIG. 10 shows a third embodiment of a surgical instrument 100 forplacement of a movement restriction device 110 for use in the surgicalprocedure for treating reflux disease in a patient. The instrument shownin the third embodiment is similar to the instrument shown in the firstembodiment and the corresponding elements are numbered alike. Theinstrument 100 comprises a sleeve 113. The sleeve 113 is connected to,or integrated with, a first handling portion 101. The first handling 101portion comprises a proximal part P and distal part D. The firsthandling portion 101 preferably comprises grooves or recesses in whichparts of a second handling portion 102 can be positioned. The secondhandling portion 102 is preferably integrated with an elongated member114 extending along the longitudinal axis inside the sleeve 113. Thesecond handling portion 102 may be formed by forming a loop of theproximal end of the elongated member such that it can be held in placein the first handling portion 101 by the grooves or recesses thereof.The elongated member may preferably be a wire. The first handlingportion 101 may further comprise at least one stopping portion 104 a,104 b adapted to stop the relative displacement of the second handlingportion 102 at a predetermined amount of displacement.

The instrument 100 further comprises a holding device 111 configured toengage and thus hold the movement restriction device 110 during thesurgical procedure. The holding device 111 is configured to be placedwithin the sleeve 113 and be displaceable in relation to the sleeve 113.The holding device 111 may be integrated with the elongated member 114such that relative displacement between the first handling portion 101and the second handling portion 102 leads to relative displacementbetween the sleeve 113 and the holding device 111. In the embodimentshown in FIG. 10 , the holding device 111 comprises a protruding memberconfigured to engage a recess of the movement restriction device 110,and thereby hold the movement restriction device 110.

Turning now to the operation of the holding device 111. FIGS. 11A and11B show the surgical instrument 100 in accordance with the thirdembodiment. In FIG. 11A, the second handling portion 102 formed as alooped proximal end of the elongated member 114, and positioned partlywithin the grooves or recesses of the first handling portion. Theproximal end of the elongated member 114 ends in the holding device 111.When the second handling portion 102 is positioned in the proximalposition in the first handling portion 101, the holding device 111extends out of the sleeve 113 such that that the holding member 111 canengage the movement restriction device 110.

The first handling portion 101 is linearly displaceable in relation tothe second handling portion 102 along the primary length axis of theinstrument. As the first handling portion 101 is integrated with thesleeve 113, linear displacement of the first handling portion 101 in thedistal direction causes the distalmost portion of the sleeve 113 to alsomove in the distal direction and thus be advanced over and passed theuppermost portion of an elongated member 114 and passed the holdingdevice 111. This relative displacement of the sleeve 113 and the holdingdevice 111 disengages the holding device 111 from the movementrestriction device 110, by the protruding member of the holding device111 being disengaged from the recess in the movement restriction device110. In practice, as shown in FIG. 11B this relative displacement can beachieved by handling the second handling portion 102 from the distalposition in the first handling portion 101 to the proximal position inthe first handling portion. This achieves a relative displacement of thesleeve 113 and the holding device 111 which disengages the holdingdevice 111 from the movement restriction device 110. The surgicalinstrument 100 thus places the movement restriction device inside of thebody of the patient and can then be removed from the abdomen.

FIGS. 12A and 12B show the surgical instrument 100 according to thethird embodiment, when positioned inside a trocar 112 in a side view.The trocar 112 assists in expanding the abdominal wall tissue such thatthe movement restriction device 110 can be positioned in the stomachwall. When the surgical instrument 100 has placed the movementrestriction device inside the body as described above, the surgicalinstrument 100 can be removed from the trocar 112 and subsequently thetrocar 112 can be removed from the body.

Please note that any embodiment or part of embodiment as well as anymethod or part of method or any apparatus or part of apparatus or anyfeature or part of feature or any system or part of system could becombined in any applicable way. All examples herein should be seen aspart of the general description and therefore possible to combine in anyway in general terms.

The invention claimed is:
 1. A surgical instrument for abdominalplacement of a movement restriction device, adapted to restrict themovement of the cardia sphincter, for use in a surgical procedure fortreating reflux disease in a patient, the instrument comprising: asleeve, a holding device configured to engage the movement restrictiondevice, wherein the holding device is configured to be placed within thesleeve and be displaceable in relation to the sleeve, a first handlingportion connected to the sleeve, and a second handling portion connectedto the holding device, wherein the handling of at least one of the firstand second handling portion creates relative displacement of the holdingdevice in relation to the sleeve, which disengages the holding devicefrom the movement restriction device for performing the placement of themovement restriction device wherein at least part of the surgicalinstrument is configured to be inserted into the abdomen of a patientthrough a trocar.
 2. The surgical instrument according to claim 1,wherein the instrument comprises: a distal portion, configured to enterthe body of the patient in use, and a proximal portion, configured toremain outside of the body of the patient in use, wherein the holdingdevice is positioned in the distal portion and the first and secondhandling portions are positioned in the proximal portion.
 3. Thesurgical instrument according to claim 1, wherein the holding device ispositioned on an elongated member connected to the second handlingportion.
 4. The surgical instrument according to claim 1, wherein theholding device comprises a protruding member configured to engage arecess of the movement restriction device.
 5. The surgical instrumentaccording to claim 1, wherein the first handling portion is linearlydisplaceable in relation to the second handling portion along a primarylength axis of the instrument.
 6. The surgical instrument according toclaim 1, wherein the first handling portion is rotationally displaceablein relation to the second handling portion around a primary length axisof the instrument.
 7. The surgical instrument according to claim 6,wherein the first handling portion comprises a threaded portion and atleast one of the second handling portion and the sleeve comprises acorresponding threaded portion, such that rotational displacement of thefirst handling portion in relation to the second handling portioncreates linear displacement of the first handling portion in relation tothe second handling portion, along the primary length axis of theinstrument.
 8. The surgical instrument according to claim 2, wherein thedistal portion is bent in relation to the primary length axis of theinstrument.
 9. The surgical instrument according to claim 8, wherein thedistal portion is bent more than 20° in relation to the primary lengthaxis of the instrument.
 10. The surgical instrument according to claim1, wherein a distal portion of the sleeve is rigid and a distal portionof the elongated member is flexible.
 11. The surgical instrumentaccording to claim 1, wherein a distal portion of the sleeve is flexibleand a distal portion of the elongated member is rigid.
 12. The surgicalinstrument according to claim 2, wherein the distal portion is flexiblesuch that the distal portion can be bent in relation to the primarylength axis of the instrument.
 13. The surgical instrument according toclaim 12, wherein the distal portion is operably flexible such that thesurgeon can bend the distal portion during the surgical procedure. 14.The surgical instrument according to claim 12, wherein the elongatedmember is operably flexible such that the surgeon can bend the distalportion during the surgical procedure.
 15. The surgical instrumentaccording to claim 12, wherein the proximal portion further comprises athird handling portion for operating the operably flexible distalportion during the surgical procedure.
 16. The surgical instrumentaccording to claim 15, wherein the third handling portion is linearlydisplaceable in relation to the second handling portion along a primarylength axis of the instrument, for operating the operably flexibledistal portion during the surgical procedure.
 17. The surgicalinstrument according to claim 15, wherein the third handling portion isrotationally displaceable in relation to the second handling portionaround a primary length axis of the instrument, for operating theoperably flexible distal portion during the surgical procedure.
 18. Thesurgical instrument according to claim 17, wherein the third handlingportion comprises a threaded portion and the second handling portioncomprises a corresponding threaded portion, such that rotationaldisplacement of the third handling portion in relation to the secondhandling portion creates linear displacement of the third handlingportion in relation to the second handling portion along the primarylength axis of the instrument, for operating the operably flexibledistal portion during the surgical procedure.
 19. The surgicalinstrument according to claim 1, wherein the sleeve comprises a rigidportion and a flexible portion configured to bend, and wherein thesleeve is displaceable relative to the holding device, such that thepoint on the surgical instrument in which the bending may start can bemoved.
 20. A surgical instrument for abdominal placement of a movementrestriction device, adapted to restrict the movement of the cardiasphincter, for use in a surgical procedure for treating reflux diseasein a patient, the instrument comprising: a sleeve, a holding deviceconfigured to engage the movement restriction device, wherein theholding device is configured to be placed within the sleeve and bedisplaceable in relation to the sleeve, a first handling portionconnected to the sleeve, and a second handling portion connected to theholding device, wherein the handling of at least one of the first andsecond handling portion creates relative displacement of the holdingdevice in relation to the sleeve, which disengages the holding devicefrom the movement restriction device for performing the placement of themovement restriction device wherein the first handling portion isrotationally displaceable in relation to the second handling portionaround a primary length axis of the instrument, and wherein the firsthandling portion comprises a threaded portion and at least one of thesecond handling portion and the sleeve comprises a correspondingthreaded portion, such that rotational displacement of the firsthandling portion in relation to the second handling portion createslinear displacement of the first handling portion in relation to thesecond handling portion, along the primary length axis of theinstrument.
 21. The surgical instrument according to claim 1, whereinthe instrument comprises: a distal portion, configured to enter the bodyof the patient in use, and a proximal portion, configured to remainoutside of the body of the patient in use, wherein the holding device ispositioned in the distal portion and the first and second handlingportions are positioned in the proximal portion.
 22. The surgicalinstrument according to claim 1, wherein the holding device ispositioned on an elongated member connected to the second handlingportion.
 23. The surgical instrument according to claim 1, wherein theholding device comprises a protruding member configured to engage arecess of the movement restriction device.
 24. The surgical instrumentaccording to claim 1, wherein the first handling portion is linearlydisplaceable in relation to the second handling portion along a primarylength axis of the instrument.
 25. The surgical instrument according toclaim 21, wherein the distal portion is bent in relation to the primarylength axis of the instrument.
 26. The surgical instrument according toclaim 25, wherein the distal portion is bent more than 20° in relationto the primary length axis of the instrument.
 27. The surgicalinstrument according to claim 20, wherein a distal portion of the sleeveis rigid and a distal portion of the elongated member is flexible. 28.The surgical instrument according to claim 1, wherein a distal portionof the sleeve is flexible and a distal portion of the elongated memberis rigid.
 29. The surgical instrument according to claim 1, wherein thedistal portion is flexible such that the distal portion can be bent inrelation to the primary length axis of the instrument.
 30. The surgicalinstrument according to claim 29, wherein the distal portion is operablyflexible such that the surgeon can bend the distal portion during thesurgical procedure.
 31. The surgical instrument according to claim 29,wherein the elongated member is operably flexible such that the surgeoncan bend the distal portion during the surgical procedure.
 32. Thesurgical instrument according to claim 29, wherein the proximal portionfurther comprises a third handling portion for operating the operablyflexible distal portion during the surgical procedure.
 33. The surgicalinstrument according to claim 32, wherein the third handling portion islinearly displaceable in relation to the second handling portion along aprimary length axis of the instrument, for operating the operablyflexible distal portion during the surgical procedure.
 34. The surgicalinstrument according to claim 32, wherein the third handling portion isrotationally displaceable in relation to the second handling portionaround a primary length axis of the instrument, for operating theoperably flexible distal portion during the surgical procedure.
 35. Thesurgical instrument according to claim 34, wherein the third handlingportion comprises a threaded portion and the second handling portioncomprises a corresponding threaded portion, such that rotationaldisplacement of the third handling portion in relation to the secondhandling portion creates linear displacement of the third handlingportion in relation to the second handling portion along the primarylength axis of the instrument, for operating the operably flexibledistal portion during the surgical procedure.
 36. The surgicalinstrument according to claim 1, wherein the sleeve comprises a rigidportion and a flexible portion configured to bend, and wherein thesleeve is displaceable relative to the holding device, such that thepoint on the surgical instrument in which the bending may start can bemoved.
 37. A surgical instrument for abdominal placement of a movementrestriction device, adapted to restrict the movement of the cardiasphincter, for use in a surgical procedure for treating reflux diseasein a patient, the instrument comprising: a sleeve, a holding deviceconfigured to engage the movement restriction device, wherein theholding device is configured to be placed within the sleeve and bedisplaceable in relation to the sleeve, a first handling portionconnected to the sleeve, and a second handling portion connected to theholding device, wherein the handling of at least one of the first andsecond handling portion creates relative displacement of the holdingdevice in relation to the sleeve, which disengages the holding devicefrom the movement restriction device for performing the placement of themovement restriction device, wherein the instrument further comprises: adistal portion, configured to enter the body of the patient in use, anda proximal portion, configured to remain outside of the body of thepatient in use, wherein the holding device is positioned in the distalportion and the first and second handling portions are positioned in theproximal portion wherein the distal portion is flexible such that thedistal portion can be bent in relation to the primary length axis of theinstrument, and wherein the proximal portion further comprises a thirdhandling portion for operating the flexible distal portion during thesurgical procedure.
 38. The surgical instrument according to claim 37,wherein the holding device is positioned on an elongated memberconnected to the second handling portion.
 39. The surgical instrumentaccording to claim 37, wherein the holding device comprises a protrudingmember configured to engage a recess of the movement restriction device.40. The surgical instrument according to claim 37, wherein the firsthandling portion is linearly displaceable in relation to the secondhandling portion along a primary length axis of the instrument.
 41. Thesurgical instrument according to claim 37, wherein the distal portion isbent in relation to the primary length axis of the instrument.
 42. Thesurgical instrument according to claim 41, wherein the distal portion isbent more than 20° in relation to the primary length axis of theinstrument.
 43. The surgical instrument according to claim 37, wherein adistal portion of the sleeve is rigid and a distal portion of theelongated member is flexible.
 44. The surgical instrument according toclaim 1, wherein a distal portion of the sleeve is flexible and a distalportion of the elongated member is rigid.
 45. The surgical instrumentaccording to claim 44, wherein the distal portion is operably flexiblesuch that the surgeon can bend the distal portion during the surgicalprocedure.
 46. The surgical instrument according to claim 44, whereinthe elongated member is operably flexible such that the surgeon can bendthe distal portion during the surgical procedure.
 47. The surgicalinstrument according to claim 37, wherein the third handling portion islinearly displaceable in relation to the second handling portion along aprimary length axis of the instrument, for operating the operablyflexible distal portion during the surgical procedure.
 48. The surgicalinstrument according to claim 37, wherein the third handling portion isrotationally displaceable in relation to the second handling portionaround a primary length axis of the instrument, for operating theoperably flexible distal portion during the surgical procedure.
 49. Thesurgical instrument according to claim 48, wherein the third handlingportion comprises a threaded portion and the second handling portioncomprises a corresponding threaded portion, such that rotationaldisplacement of the third handling portion in relation to the secondhandling portion creates linear displacement of the third handlingportion in relation to the second handling portion along the primarylength axis of the instrument, for operating the operably flexibledistal portion during the surgical procedure.
 50. The surgicalinstrument according to claim 37, wherein the sleeve comprises a rigidportion and a flexible portion configured to bend, and wherein thesleeve is displaceable relative to the holding device, such that thepoint on the surgical instrument in which the bending may start can bemoved.
 51. A surgical instrument for abdominal placement of a movementrestriction device, adapted to restrict the movement of the cardiasphincter, for use in a surgical procedure for treating reflux diseasein a patient, the instrument comprising: a sleeve, a holding deviceconfigured to engage the movement restriction device, wherein theholding device is configured to be placed within the sleeve and bedisplaceable in relation to the sleeve, a first handling portionconnected to the sleeve, and a second handling portion connected to theholding device, wherein the handling of at least one of the first andsecond handling portion creates relative displacement of the holdingdevice in relation to the sleeve, which disengages the holding devicefrom the movement restriction device for performing the placement of themovement restriction device wherein the distal portion is bent inrelation to the primary length axis of the instrument.
 52. The surgicalinstrument according to claim 51, wherein the holding device ispositioned on an elongated member connected to the second handlingportion.
 53. The surgical instrument according to claim 51, wherein theholding device comprises a protruding member configured to engage arecess of the movement restriction device.
 54. The surgical instrumentaccording to claim 51, wherein the first handling portion is linearlydisplaceable in relation to the second handling portion along a primarylength axis of the instrument.
 55. The surgical instrument according toclaim 51, wherein the distal portion is bent more than 20° in relationto the primary length axis of the instrument.
 56. The surgicalinstrument according to claim 51, wherein a distal portion of the sleeveis rigid and a distal portion of the elongated member is flexible. 57.The surgical instrument according to claim 51, wherein a distal portionof the sleeve is flexible and a distal portion of the elongated memberis rigid.
 58. The surgical instrument according to claim 57, wherein thedistal portion is operably flexible such that the surgeon can bend thedistal portion during the surgical procedure.
 59. The surgicalinstrument according to claim 57, wherein the elongated member isoperably flexible such that the surgeon can bend the distal portionduring the surgical procedure.
 60. The surgical instrument according toclaim 51, wherein the third handling portion is linearly displaceable inrelation to the second handling portion along a primary length axis ofthe instrument, for operating the operably flexible distal portionduring the surgical procedure.
 61. The surgical instrument according toclaim 51, wherein the third handling portion is rotationallydisplaceable in relation to the second handling portion around a primarylength axis of the instrument, for operating the operably flexibledistal portion during the surgical procedure.
 62. The surgicalinstrument according to claim 61, wherein the third handling portioncomprises a threaded portion and the second handling portion comprises acorresponding threaded portion, such that rotational displacement of thethird handling portion in relation to the second handling portioncreates linear displacement of the third handling portion in relation tothe second handling portion along the primary length axis of theinstrument, for operating the operably flexible distal portion duringthe surgical procedure.
 63. The surgical instrument according to claim51, wherein the sleeve comprises a rigid portion and a flexible portionconfigured to bend, and wherein the sleeve is displaceable relative tothe holding device, such that the point on the surgical instrument inwhich the bending may start can be moved.